CMS Releases Medicare Advantage and Part D Drug Pricing Proposed Rule for Contract Year 2020

by Epstein Becker & Green
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On November 26, 2018, the Centers for Medicare & Medicaid Services (“CMS”) issued a proposed rule titled “Modernizing Part D and Medicare Advantage to Lower Drug Prices and Reduce Out-of-Pocket Expenses” (“Proposed Rule”).[1]

The agency has proposed five changes to amend Medicare Advantage (“MA”) and Medicare Prescription Drug Benefit (“Part D”) regulations to support health and drug plans’ negotiation for lower drug prices and to reduce out-of-pocket costs for MA and Part D enrollees. This Client Alert summarizes the major provisions of the Proposed Rule.

The Proposed Rule also includes regulations addressing the recently enacted “Know the Lowest Price Act,” which was signed into law by President Trump in October and which creates a prohibition against pharmacy gag clauses.  

CMS is requesting that the public submit comments on the Proposed Rule, which must be received by CMS no later than 5 p.m. EST on January 25, 2019. This Client Alert sets forth and highlights the specific issues with which CMS has solicited comments.  

  1. Providing Plan Flexibility to Manage Protected Classes

The Trump administration has stated on multiple occasions, including in its May 2018 Blueprint, its intention to provide Medicare Part D more tools to negotiate lower prices for drugs in “protected classes” that are available in the private sector.[2] The Part D “protected class” policy requires Part D sponsors to include, with limited exceptions, all drugs in six categories or classes (antidepressants, antipsychotics, anticonvulsants, immunosuppressants for treatment of transplant rejection, antiretrovirals, and antineoplastics) in their formularies. Due to its belief that the current policy makes it difficult for Part D sponsors to negotiate for lower costs and rebates, CMS is proposing three new exceptions to the protected class policy:

  1. Implementation of Broader Use of Prior Authorization and Step Therapy

This proposed exception would allow Part D sponsors to use prior authorization and step therapy for protected class drugs without regard to whether the therapy is new or existing. In the preamble, CMS expresses concerns that the current limits of such drug utilization management (“UM”) techniques leads to overutilization of protected class drugs among Part D enrollees, including protected class drugs used for medically-accepted indications (e.g., FDA approved uses) that are not protected class indications. Under the Proposed Rule, prior authorization requirements would be allowed for any protected class drug to confirm that it is being used for a protected class indication, ensure clinically appropriate use, and promote utilization of preferred formulary alternatives. Such utilization management tools would continue to be subject to CMS review and approval, and CMS states it would not support onerous prior authorization criteria.

COMMENTS NEEDED

CMS is seeking comments on whether the exception regarding the broader use of prior authorization and step therapy should be limited to new starts only.

  1. Exclusion of New Formulations of Existing Single-Source Drugs or Biological Products in a Protected Class from a Formulary Regardless of Whether the Older Formulation Remains on the Market

If finalized, Part D sponsors would be permitted to exclude from their formularies a new formulation of a protected class drug that does not provide a unique route of administration regardless of whether the older formulation remains on the market. CMS is seeking this change to ensure that manufacturers cannot force Part D sponsors to add new products to their formularies by withdrawing from the market older formulations of a drug or biological product when introducing a new, more expensive formulation.

  1. Exclusion of a Protected Class Drug from a Formulary if a Drug Price Increases Beyond a Certain Threshold Over a Specified Look-Back Period

Citing support that protected class drug prices have increased more than other, non-protected drug classes between 2012 and 2017, CMS is proposing to permit Part D sponsors to exclude a protected class drug if the drug’s price increased, relative to the price in a baseline month and year, beyond the rate of inflation. The exception would be effective for plan years starting on or after January 1, 2020. The rate of inflation is to be calculated using the Consumer Price Index for all Urban Consumers (“CPI-U”). This exception would apply if between the baseline date and any point in the “applicable period”[3] a drug’s wholesale acquisition cost (“WAC”) increased more than the cumulative increase in CPI-U over the same period. To decrease opportunities for price gaming, and so that any price increases planned prior to the release of the Proposed Rule would not be incorporated and result in a higher baseline, CMS proposes September 1, 2018, as the baseline date for all drugs on the market as of that date. For drugs that enter the market after September 1, 2018, the baseline date would be the first full quarter after the launch date.

Part D sponsors would be responsible for monitoring price increases, determining the cumulative CPI-U increases for the corresponding applicable periods, and deciding whether they wish to submit a formulary that excludes the protected class drugs with price increases above the inflation rate. Just because a protected class drug can be excluded from the formulary under this Proposed Rule does not mean exclusion must occur—manufacturers and sponsors can instead negotiate rebate arrangements for formulary placement. Drugs excluded through this exception would be excluded only for the contract year. Part D sponsors wishing to exclude the drug for subsequent years must continue to monitor whether the WAC of the drug increased faster than the inflation rate for the next contract year’s applicable period.

Key Takeaway: Part D sponsors and their pharmacy benefit managers (“PBMs”) will appreciate the additional flexibility and leverage to negotiate prices and rebates afforded by the proposed exceptions. However, drug manufacturer and patient groups have been quick to criticize the proposal on the basis that it may allow Part D sponsors to discriminate against certain categories of “high cost” beneficiaries.[4] In 2014, CMS faced similar criticism from such stakeholders when it proposed more aggressive regulations to remove the protected status of three drug classes. After facing mounting resistance and significant comments, CMS did not include the proposal in the final rule. It remains to seen whether CMS’s more moderate proposal to provide Part D sponsors more flexibility to manage protected class drugs, without eliminating any classes, will limit the magnitude of opposition.

COMMENTS NEEDED

CMS seeks comments on the following:

  • whether an alternative pricing threshold to CPI-U should be considered;
  • whether an increase in price other than the drug’s WAC (such as negotiated price or some other standard) should be used to determine whether the protected class drug could be excluded from the Part D formulary;
  • whether the protected class drug exception’s policy should apply only to single-source drugs and biological products or whether a broader mix of drugs should be eligible for formulary exclusion in accordance with the proposed exception policy;
  • the merits of the proposal to have Part D sponsors operationalize the protected class drug exception policy by monitoring changes in WAC and CPI-U or if there is a more effective approach;
  • whether an increase in WAC beyond CPI-U for any national drug code (“NDC”) assigned to a particular brand of drug or single-source generic drug should be grounds for allowing a sponsor to exclude all NDCs assigned to that drug from the formulary;
  • whether WAC as of some date other than September 1, 2018, should be used as the baseline WAC for drugs on the market before September 1, 2018;
  • whether to propose that a Part D sponsor could exclude a protected class drug from its formulary for any future contract year once its WAC increased more rapidly than the cumulative increase in inflation;
  • whether to propose a price threshold exception to all drugs in the protected classes of a given manufacturer if any one of those drugs’ WAC, when compared to baseline WAC, increases beyond the cumulative rate of inflation;
  • the impact of this policy proposal on Part D enrollees;
  • whether there are additional considerations that would be necessary to minimize interruptions in existing therapy of protected class drugs for protected class drug indications during prior authorization processes;
  • whether there are additional considerations that would be necessary to minimize increases in overall Medicare spending from increased utilization of services secondary to adverse events from interruptions in therapy, and why current requirements are inadequate or could be improved; and
  • what specific patient populations, individual patient characteristics, specific protected class drugs, or individual protected drug classes would require additional special transition processes or other protections and how such populations can be consistently identified.
  1. E-Prescribing and the Part D Prescription Drug Program; Updating Part D E-Prescribing Standards

Beginning contract year 2020, CMS proposes to require Part D sponsors to implement a real-time benefit tool (“RTBT”) in order to make beneficiary-specific drug coverage, formulary options, and cost data visible to prescribers who wish to use such data at the point of prescribing. Through the RTBT, CMS aims to foster price transparency to aid in lowering overall drug costs and patient out-of-pocket costs and to improve medication adherence.

In the preamble to the Proposed Rule, CMS recognizes that while there is no current industry standard for RTBTs, technologies exist that can interface with electronic medical record (“EMR”) systems to allow for this function. CMS notes that PBMs and a few plans have successfully implemented RTBTs for a small subsection of enrollment. The Proposed Rule would require Part D sponsors to select or develop an RTBT that would be capable of integrating with at least one prescriber’s EMR and e-prescribing system. The RTBT would need to show how the prescription claim would be adjudicated given the information submitted and the claims history of the patient, including the patient’s cost-sharing information, additional formulary alternatives, and relevant indications that could impact coverage. In the preamble, CMS states that it is also encouraging plans to promote full drug cost transparency by showing each drug’s full “negotiated price” (as defined in Part D regulations), although this is not a requirement in the Proposed Rule.

To the extent prescribers and dispensers implement e-prescribing, CMS requires that they comply with applicable standards in effect. Currently, e-prescribing standards include the NCPDP SCRIPT e-prescribing standard for transactions (“SCRIPT”), and the NCPDC Formulary and Benefits (“F&B”) standard. The RTBT would function alongside the existing SCRIPT and F&B standards. CMS found the existing F&B standard inadequate to provide this RTBT function because the existing F&B standard lacks beneficiary-specific formulary information and solely provides batch-only functionality (as opposed to real-time).

Key Takeaway: Since there is no current standard for RTBT implementation and operability across the various Part D sponsors and EMR systems, the development of an RTBT may impose implementation challenges to Part D sponsors (and their PBMs). On the other hand, the proposed requirement presents a significant opportunity for health technology vendors in the EMR and eRx space that have developed or are in a position to develop this tool. How RTBTs will influence the selection of therapies by patients and prescribers in a broader market remains to be seen.

COMMENTS NEEDED

CMS seeks comment on the RTBT proposal as well as the following:

  • standards that are currently under development that may be suitable to meet the needs of this RTBT function;
  • the feasibility for plans, and the impact on industry and other stakeholders, of the proposed January 1, 2020, deadline;
  • how this proposal may, or may not, expedite CMS’s goal of giving access to meaningful decision support through RTBT to beneficiaries and their clinicians;
  • RTBT standardization efforts, including efforts by standardization bodies;
  • whether this proposal would be contrary to advancing RTBT within Part D; and
  • the impact of this proposal on plans and providers regarding overall interoperability and the impact to medical record systems.
  1. Medicare Advantage and Step Therapy for Part B Drugs

MA plans were early adopters of UM techniques, such as prior authorization, medication formularies, and step therapy, to manage health care benefit costs by assessing the appropriateness of clinical interventions using evidence-based criteria or guidelines. Currently, UM is not permitted for Part B drugs under traditional Medicare. On August 7, 2018, CMS reversed this position and recognized that under certain conditions, MA plans may implement step therapy for Part B drugs beginning in contract year 2019.[5] This acknowledged step therapy as an officially sanctioned UM technique for both Medicare and the private MA programs.

The Proposed Rule would codify this change in policy to expand MA plans’ existing authority to implement appropriate utilization management and prior authorization programs for the management of Part B drugs while creating requirements that plans must follow in order to do so. This change provides a platform to mandate utilization of lower-cost pharmaceutical interventions prior to resorting to drugs on the high-cost tiers. The change is intended to enable MA plans and enrollees to pay less for drugs while maintaining patient access to necessary treatment. Perhaps signaling a recognition of clinical efficacy over promotion, the changes further permit MA plans to require an enrollee to try and fail off-label medically-accepted indications before providing access to a drug for an FDA-approved indication (i.e., to institute a “fail first” requirement).

The Proposed Rule would add a new regulation at 42 C.F.R. § 422.136 titled “Medicare Advantage and Step Therapy for Part B Drugs.” The changes would allow MA plans to offer beneficiaries the most cost-effective Part B drug before progressing to other, more costly options.

Anticipating critics, CMS denies in the Proposed Rule that this change would restrict access to necessary medications, indicating that the Proposed Rule is “embedded with strong patient protections” that will ensure quality treatment is not sacrificed. These protections include the disclosure of step therapy in benefits offerings, an appeals process, response timelines, and continuity of care.

  1. Disclosure Requirements

MA plans would be required to disclose that Part B drugs may be subject to step therapy requirements in a plan’s Annual Notice of Change (“ANOC”) to Benefits and Costs for Medical Services and Evidence of Coverage (“EOC”) Medicare Part B prescription drug documents. Under existing requirements, MA plans must establish policies and procedures to fully inform contracted health care providers of UM methodology. CMS proposes that these MA policies and procedures include specific disclosures related to step therapy policies. MA plans must also explain coverage rules, practice guidelines, payment policies, and procedures allowing for individual medical necessity determinations.

  1. Determination and Appeals Processes

The Proposed Rule requires MA plans to administer a determination and appeals process if they choose to implement step therapy for Part B drugs. Enrollees can request a determination if they believe that they need direct access to a covered Part B drug without first trying the cost-effective biosimilar. Such determination may be standard or expedited due to the medical condition of the enrollee. MA plans would review this determination based upon medical necessity criteria. If dissatisfied with this initial determination, the enrollee can appeal.

Additional protections include a committee review and approval of step therapy programs as well as shorter timeframes for adjudication requests (no later than 24 hours for expedited determinations and 72 hours for standard determination requests). Also, step therapy would only be permitted for new prescriptions or administrations of Part B drugs for enrollees not actively receiving the affected medication.

Key Takeaway: CMS indicates that the primary aim of permitting MA plans to implement step therapy for Part B drugs is to increase MA plans’ negotiating power with pharmaceutical companies. It is likely that manufacturers will face stronger competition for favorable formulary placement and heightened pressure to discount more expensive drugs. By reducing overall pharmacy spend, patients and providers may receive the added benefit of access to new clinical interventions as insurers move to meet the medical loss ratio spend requirements. However, it is also likely that patients will encounter additional process hurdles and delays; even if access is not denied, it may be hampered.

COMMENTS NEEDED

CMS is seeking comments concerning:

  • the impact that allowing step therapy for Part B drugs would have on MA plans and enrollees;
  • the proposal that MA plans with step therapy programs would be required to have Pharmacy and Therapeutics (“P&T”) committees;
  • the use of off-label drugs in the step therapy programs; and
  • the organization’s determination and appeals timelines and processes that would be applicable to Part B drugs.
  1. Pharmacy Price Concessions to Drug Prices at the Point of Sale

In the Proposed Rule, CMS considers adopting a new definition of “negotiated price” to include all pharmacy price concessions received by the plan sponsor for a Part D drug.

This proposal follows from a prior request for information issued by CMS in November of 2017 (“RFI”), which was addressed in a prior Epstein Becker Green Health Care & Life Sciences Client Alert.[6] Pharmacy price concessions, which are negotiated between pharmacies and Part D sponsors or their PBMs, are often tied to the pharmacy’s performance on various defined measures. Currently, the definition of “negotiated price” includes all price concessions except those that cannot reasonably be determined at the point of sale. CMS notes that generally such pharmacy performance adjustments are not included in the drug’s price at the point of sale because these adjustments typically occur after the point of sale, such that they are reported to CMS as direct and indirect remuneration (“DIR”) at the end of the coverage year. The definition of “negotiated price” is used to calculate the beneficiary’s cost-share as well as the reimbursement amount paid to the dispensing provider of the Part D drug. In turn, this negotiated price determines plan, beneficiary, manufacturer, and government liability during the course of a given year, subject to final reconciliation.

CMS highlighted several policy concerns related to pharmacy price concessions being counted as DIR:

  • Including more pharmacy price concessions as DIR instead of at the point of sale creates a profit incentive for Part D plan sponsors to have higher negotiated prices along with higher DIR.
  • The growth in pharmacy price concessions creates difficulty for consumers to understand the beneficiary share of the drug’s price they pay versus what the plan pays (this is important because reflecting pharmacy price concessions as end-of-year DIR rather than including in the negotiated price may serve to shift costs to the beneficiary).
  • When Part D sponsors recognize pharmacy price concessions as DIR rather than include them in negotiated prices, they may be able to reduce their plan bids to achieve lower plan premiums in an effort to gain a competitive advantage based on technical differences in how costs are reported.
  • This scenario may also create competitive concerns by discouraging independent pharmacies from participating in plan networks.
  1. “Negotiated Price” Definition

CMS is proposing to redefine “negotiated price” to mean the lowest amount that a pharmacy could receive as reimbursement for a Part D drug. CMS proposes to remove from the definition the exception for amounts that cannot be “reasonably determined at the point of sale.” The agency also proposes to require that all contingent incentive payments be excluded from “negotiated price.” CMS believes that the new definition would address the above issues by providing more meaningful price transparency, allowing consistent application of pharmacy payment concessions by Part D sponsors and preventing cost-shifting to beneficiaries and taxpayers.

  1. Lowest Possible Reimbursement Requirement

CMS proposes to require the negotiated price to reflect the lowest possible reimbursement that a pharmacy could receive from a specific Part D sponsor, thereby capturing all pharmacy price concessions at the point of sale in a consistent manner across sponsors. Regarding performance-based contingent payment arrangements between a pharmacy and a sponsor, CMS proposes to mandate that reported point of sale price reflect the final payment to the pharmacy as if the pharmacy were to receive the lowest possible performance score (i.e., the scenario where the sponsor recoups the maximum amount from the pharmacy for poor performance). If the pharmacy ultimately does not receive the lowest performance score possible, CMS proposes to require that a negative DIR amount be reported, which reflects the difference between the “negotiated price” and the final payment received by the pharmacy, to “true up” the DIR reported to the actual amount. Upon review of comments submitted to the RFI, CMS notes that pharmacies rarely receive an incentive payment above the original reimbursement rate for the drug claim.

  1. Other Related Issues

CMS proposes to utilize existing reporting mechanisms (i.e., prescription drug event records and DIR reports) when implementing this proposal to ensure proper application of the pharmacy price concessions at the point of sale. CMS is considering whether to require sponsors to include pharmacy price concessions in the negotiated price for beneficiaries in the coverage gap, for the purpose of determining manufacturer coverage gap discount liability. CMS is considering an option to develop a standard set of metrics on which plans and pharmacies would base their contractual agreements. CMS is considering creating a definition of “price concession,” which would be broadly defined, to include all forms of discounts, direct or indirect subsidies, or rebates.

COMMENTS NEEDED

CMS seeks comments on the following aspects of the proposal regarding pharmacy price concessions:

  • whether CMS should move forward with this proposal, effective for contract year 2020;
  • alternate approaches to requiring sponsors to include pharmacy price concessions in the negotiated price in the coverage gap;
  • alternatives to the lowest possible reimbursement approach that would require Part D sponsors to apply less than 100 percent of pharmacy price concessions at the point of sale; and
  • whether plan/pharmacy metrics could be designed to provide pharmacies with more predictability in their reimbursement while maintaining a plan’s ability to negotiate terms, and which agency or organization would be the most appropriate to develop such standards.

Key Takeaway: Notably in the Proposed Rule, CMS did not address the topic of passing along a percentage of manufacturer rebates at the point of sale, as discussed in CMS’s November 2017 RFI. Because Part D plan sponsors receive the vast majority of price concessions from manufacturers, rather than pharmacies, the reform is unlikely to produce dramatic cost savings at the pharmacy point of sale. Nevertheless, it would have a significant impact on contractual relations between Part D plan sponsors, PBMs, and network pharmacies. In anticipation of the finalization of this regulation, Part D sponsors will need to prepare to make adjustments in how they report negotiated prices and pharmacy price concessions. The method of calculating the lowest possible reimbursement to implement this new proposed definition of “negotiated price” appears to set a default calculation baseline but may not comport with current industry practice.

V. Part D Explanation of Benefits

Currently, Part D sponsors are required to furnish each of their enrollees with a written explanation of benefits (“EOB”). When drugs are provided, Part D sponsors are required to provide enrollees with a notice of benefits in relation to the initial coverage limit and out-of-pocket threshold for the current year. Neither the EOB nor the notice of benefits requires the inclusion of information about negotiated drug price changes or lower-cost alternatives. The Trump administration’s May 2018 Blueprint solicited feedback on improving the usefulness of the Part D EOB statement by including information about drug price changes and lower-cost alternatives. Citing the supportive comments received, CMS proposes to require the inclusion of negotiated drug pricing information and lower-cost alternatives in the Part D EOB in order to provide enrollees with greater transparency and thereby encourage lower costs. In addition, CMS believes this proposed change would better educate beneficiaries on drug prices and empower them to make more informed decisions when choosing a prescription drug.

CMS proposes to require Part D sponsors to include a cumulative percentage change in the negotiated drug price since the first day of the current benefit year for each prescription drug claim in the EOB. CMS solicits feedback on operationalizing this in the EOB to best serve beneficiaries, which could include information such as the percent change in the negotiated price since the close of open enrollment in addition to the percent change in price since the first day of the benefit year.

CMS also proposes to require Part D sponsors to provide information about drugs that are therapeutic alternatives with lower cost sharing, when available, as determined by the applicable approved plan formulary for each prescription drug claim. CMS encourages, but does not require, sponsors to provide relevant beneficiary-specific information.

COMMENTS NEEDED

CMS seeks comments on the proposed changes to Part D EOB, including the impact on the beneficiary.

Key Takeaway: In the absence of beneficiary-specific information, there would appear to be a high likelihood of confusion regarding whether alternatives are appropriate for that particular patient, which may increase the burden on providers or plans to field these questions.

VI. Prohibition Against Pharmacy Gag Clauses

On October 10, 2018, President Trump signed into law the Know the Lowest Price Act, which prohibits “gag order” clauses in contracts between pharmacies and PBMs that are designed to bar pharmacists from disclosing to Medicare beneficiaries at the pharmacy point of sale whether or not a drug’s cash price would be lower than the beneficiary’s cost-sharing burden under his or her prescription drug plan.[7] The new law, which will go into effect on January 1, 2020, follows upon the Trump administration’s previously announced plan to ban gag order clauses in its May 2018 Blueprint.

The Proposed Rule includes new regulations that will implement the recently enacted law’s pharmacy “gag order” prohibition under Medicare Part D. Specifically, the Proposed Rule would amend the pharmacy contracting requirements at Section 423.120(a)(8) by adding language that a Part D sponsor may not prohibit a pharmacy from, or penalize a pharmacy for, informing Part D plan beneficiaries of a lower cash price available at that pharmacy for a prescription medication that a beneficiary would pay more out-of-pocket for if purchased through the Part D plan. CMS acknowledges that it would simply be codifying existing practice with this proposed change. Accordingly, the new regulatory language is not expected to produce savings or costs.

Key Takeaway: The new federal prohibition on pharmacy gag clauses, which CMS proposes to implement through regulation, has been embraced by pharmacy interests and will help ensure and promote transparency between pharmacists and beneficiaries under the Medicare program.[8] Nevertheless, the practical impact of the reform may be moderated by the fact that many PBMs no longer incorporate these clauses in their pharmacy contracts, largely due to existing laws in several states that prohibit the practice.

ENDNOTES

[1] 83 Fed. Reg. 62,152 (Nov. 30, 2018).

[2] Alex Azar & Seema Verma, Proposed Changes to Lower Drug Prices in Medicare Advantage and Part D, Ctrs. for Medicare & Medicaid Servs. (Nov. 26, 2018), https://www.cms.gov/blog/proposed-changes-lower-drug-prices-medicare-advantage-and-part-d. See also, U.S. Dep’t of Health & Human Servs., American Patients First (May 2018), available at https://www.hhs.gov/sites/default/files/AmericanPatientsFirst.pdf (outlining the Trump administration’s ideas to decrease health care costs).

[3] CMS proposes to add definitions for “applicable period”—for contract year 2020, the applicable period will be September 1, 2018, through February 28, 2019, and for contract year 2021 and subsequent years, the applicable period will be September 1 of the third year prior to the contract year in which the exception would apply, through August 31 of the second year prior to the contract year in which the exception would apply. To provide additional clarity, a timeline is included in Table 1 of the proposed regulations.

[4] See, e.g., BIO Statement on Proposed Changes to Medicare Advantage and Part D Plans, Biotechnology Innovation Org. (Nov. 26, 2018), https://www.bio.org/press-release/bio-statement-proposed-changes-medicare-advantage-and-part-d-plans (discussing the Proposed Rule’s negative impact on seniors’ access to drugs); CMS Proposal Effectively Unprotects Six Protected Classes, Cmty. Oncology All. (Nov. 27, 2018), https://www.communityoncology.org/coa-cms-proposal-effectively-unprotects-six-protected-classes/ (describing the Proposed Rule as “a potential nightmare for vulnerable patients with cancer”); NFK Concerned about Proposed Changes to Medicare Part D, Nat’l Kidney Found. (Nov. 26, 2018), https://www.kidney.org/news/nkf-concerned-about-proposed-changes-to-medicare-part-d (expressing concern that the proposed changes would make it more difficult for transplant recipients to access needed drugs).

[5] Ctrs. for Medicare & Medicaid Servs., Medicare Advantage Prior Authorization and Step Therapy for Part B Drugs (Aug. 7, 2018), https://www.cms.gov/newsroom/fact-sheets/medicare-advantage-prior-authorization-and-step-therapy-part-b-drugs.

[6] Constance Wilkinson, et al., Comment Deadline Approaches for CMS’s Proposed Changes to Medicare Advantage and Part D Programs for CY 2019 – Part 1: Negotiated Prices for Drugs, Epstein Becker & Green (Jan. 3, 2018), https://www.ebglaw.com/news/comment-deadline-approaches-for-cmss-proposed-changes-to-medicare-advantage-and-part-d-programs-for-cy-2019-part-1-negotiated-prices-for-drugs/.

[7] GovTrack, S. 2553: Know the Lowest Price Act of 2018 (Oct. 10, 2018), https://www.govtrack.us/congress/bills/115/s2553/summary.

[8] See Lynn Snyder, et al., New Federal Laws Banning “Gag Clauses” in the Pharmacy, Health L. Advisor (Oct. 19, 2018), https://www.healthlawadvisor.com/2018/10/19/new-federal-laws-banning-gag-clauses-in-the-pharmacy/ (explaining the implications of the Know the Lowest Price Act).

 

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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Links to Other Websites

Our Website and Services may contain links to other websites. The operators of such other websites may collect information about you, including through cookies or other technologies. If you are using our Website or Services and click a link to another site, you will leave our Website and this Policy will not apply to your use of and activity on those other sites. We encourage you to read the legal notices posted on those sites, including their privacy policies. We are not responsible for the data collection and use practices of such other sites. This Policy applies solely to the information collected in connection with your use of our Website and Services and does not apply to any practices conducted offline or in connection with any other websites.

Information for EU and Swiss Residents

JD Supra's principal place of business is in the United States. By subscribing to our website, you expressly consent to your information being processed in the United States.

  • Our Legal Basis for Processing: Generally, we rely on our legitimate interests in order to process your personal information. For example, we rely on this legal ground if we use your personal information to manage your Registration Data and administer our relationship with you; to deliver our Website and Services; understand and improve our Website and Services; report reader analytics to our authors; to personalize your experience on our Website and Services; and where necessary to protect or defend our or another's rights or property, or to detect, prevent, or otherwise address fraud, security, safety or privacy issues. Please see Article 6(1)(f) of the E.U. General Data Protection Regulation ("GDPR") In addition, there may be other situations where other grounds for processing may exist, such as where processing is a result of legal requirements (GDPR Article 6(1)(c)) or for reasons of public interest (GDPR Article 6(1)(e)). Please see the "Your Rights" section of this Privacy Policy immediately below for more information about how you may request that we limit or refrain from processing your personal information.
  • Your Rights
    • Right of Access/Portability: You can ask to review details about the information we hold about you and how that information has been used and disclosed. Note that we may request to verify your identification before fulfilling your request. You can also request that your personal information is provided to you in a commonly used electronic format so that you can share it with other organizations.
    • Right to Correct Information: You may ask that we make corrections to any information we hold, if you believe such correction to be necessary.
    • Right to Restrict Our Processing or Erasure of Information: You also have the right in certain circumstances to ask us to restrict processing of your personal information or to erase your personal information. Where you have consented to our use of your personal information, you can withdraw your consent at any time.

You can make a request to exercise any of these rights by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

You can also manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard.

We will make all practical efforts to respect your wishes. There may be times, however, where we are not able to fulfill your request, for example, if applicable law prohibits our compliance. Please note that JD Supra does not use "automatic decision making" or "profiling" as those terms are defined in the GDPR.

  • Timeframe for retaining your personal information: We will retain your personal information in a form that identifies you only for as long as it serves the purpose(s) for which it was initially collected as stated in this Privacy Policy, or subsequently authorized. We may continue processing your personal information for longer periods, but only for the time and to the extent such processing reasonably serves the purposes of archiving in the public interest, journalism, literature and art, scientific or historical research and statistical analysis, and subject to the protection of this Privacy Policy. For example, if you are an author, your personal information may continue to be published in connection with your article indefinitely. When we have no ongoing legitimate business need to process your personal information, we will either delete or anonymize it, or, if this is not possible (for example, because your personal information has been stored in backup archives), then we will securely store your personal information and isolate it from any further processing until deletion is possible.
  • Onward Transfer to Third Parties: As noted in the "How We Share Your Data" Section above, JD Supra may share your information with third parties. When JD Supra discloses your personal information to third parties, we have ensured that such third parties have either certified under the EU-U.S. or Swiss Privacy Shield Framework and will process all personal data received from EU member states/Switzerland in reliance on the applicable Privacy Shield Framework or that they have been subjected to strict contractual provisions in their contract with us to guarantee an adequate level of data protection for your data.

California Privacy Rights

Pursuant to Section 1798.83 of the California Civil Code, our customers who are California residents have the right to request certain information regarding our disclosure of personal information to third parties for their direct marketing purposes.

You can make a request for this information by emailing us at privacy@jdsupra.com or by writing to us at:

Privacy Officer
JD Supra, LLC
10 Liberty Ship Way, Suite 300
Sausalito, California 94965

Some browsers have incorporated a Do Not Track (DNT) feature. These features, when turned on, send a signal that you prefer that the website you are visiting not collect and use data regarding your online searching and browsing activities. As there is not yet a common understanding on how to interpret the DNT signal, we currently do not respond to DNT signals on our site.

Access/Correct/Update/Delete Personal Information

For non-EU/Swiss residents, if you would like to know what personal information we have about you, you can send an e-mail to privacy@jdsupra.com. We will be in contact with you (by mail or otherwise) to verify your identity and provide you the information you request. We will respond within 30 days to your request for access to your personal information. In some cases, we may not be able to remove your personal information, in which case we will let you know if we are unable to do so and why. If you would like to correct or update your personal information, you can manage your profile and subscriptions through our Privacy Center under the "My Account" dashboard. If you would like to delete your account or remove your information from our Website and Services, send an e-mail to privacy@jdsupra.com.

Changes in Our Privacy Policy

We reserve the right to change this Privacy Policy at any time. Please refer to the date at the top of this page to determine when this Policy was last revised. Any changes to our Privacy Policy will become effective upon posting of the revised policy on the Website. By continuing to use our Website and Services following such changes, you will be deemed to have agreed to such changes.

Contacting JD Supra

If you have any questions about this Privacy Policy, the practices of this site, your dealings with our Website or Services, or if you would like to change any of the information you have provided to us, please contact us at: privacy@jdsupra.com.

JD Supra Cookie Guide

As with many websites, JD Supra's website (located at www.jdsupra.com) (our "Website") and our services (such as our email article digests)(our "Services") use a standard technology called a "cookie" and other similar technologies (such as, pixels and web beacons), which are small data files that are transferred to your computer when you use our Website and Services. These technologies automatically identify your browser whenever you interact with our Website and Services.

How We Use Cookies and Other Tracking Technologies

We use cookies and other tracking technologies to:

  1. Improve the user experience on our Website and Services;
  2. Store the authorization token that users receive when they login to the private areas of our Website. This token is specific to a user's login session and requires a valid username and password to obtain. It is required to access the user's profile information, subscriptions, and analytics;
  3. Track anonymous site usage; and
  4. Permit connectivity with social media networks to permit content sharing.

There are different types of cookies and other technologies used our Website, notably:

  • "Session cookies" - These cookies only last as long as your online session, and disappear from your computer or device when you close your browser (like Internet Explorer, Google Chrome or Safari).
  • "Persistent cookies" - These cookies stay on your computer or device after your browser has been closed and last for a time specified in the cookie. We use persistent cookies when we need to know who you are for more than one browsing session. For example, we use them to remember your preferences for the next time you visit.
  • "Web Beacons/Pixels" - Some of our web pages and emails may also contain small electronic images known as web beacons, clear GIFs or single-pixel GIFs. These images are placed on a web page or email and typically work in conjunction with cookies to collect data. We use these images to identify our users and user behavior, such as counting the number of users who have visited a web page or acted upon one of our email digests.

JD Supra Cookies. We place our own cookies on your computer to track certain information about you while you are using our Website and Services. For example, we place a session cookie on your computer each time you visit our Website. We use these cookies to allow you to log-in to your subscriber account. In addition, through these cookies we are able to collect information about how you use the Website, including what browser you may be using, your IP address, and the URL address you came from upon visiting our Website and the URL you next visit (even if those URLs are not on our Website). We also utilize email web beacons to monitor whether our emails are being delivered and read. We also use these tools to help deliver reader analytics to our authors to give them insight into their readership and help them to improve their content, so that it is most useful for our users.

Analytics/Performance Cookies. JD Supra also uses the following analytic tools to help us analyze the performance of our Website and Services as well as how visitors use our Website and Services:

  • HubSpot - For more information about HubSpot cookies, please visit legal.hubspot.com/privacy-policy.
  • New Relic - For more information on New Relic cookies, please visit www.newrelic.com/privacy.
  • Google Analytics - For more information on Google Analytics cookies, visit www.google.com/policies. To opt-out of being tracked by Google Analytics across all websites visit http://tools.google.com/dlpage/gaoptout. This will allow you to download and install a Google Analytics cookie-free web browser.

Facebook, Twitter and other Social Network Cookies. Our content pages allow you to share content appearing on our Website and Services to your social media accounts through the "Like," "Tweet," or similar buttons displayed on such pages. To accomplish this Service, we embed code that such third party social networks provide and that we do not control. These buttons know that you are logged in to your social network account and therefore such social networks could also know that you are viewing the JD Supra Website.

Controlling and Deleting Cookies

If you would like to change how a browser uses cookies, including blocking or deleting cookies from the JD Supra Website and Services you can do so by changing the settings in your web browser. To control cookies, most browsers allow you to either accept or reject all cookies, only accept certain types of cookies, or prompt you every time a site wishes to save a cookie. It's also easy to delete cookies that are already saved on your device by a browser.

The processes for controlling and deleting cookies vary depending on which browser you use. To find out how to do so with a particular browser, you can use your browser's "Help" function or alternatively, you can visit http://www.aboutcookies.org which explains, step-by-step, how to control and delete cookies in most browsers.

Updates to This Policy

We may update this cookie policy and our Privacy Policy from time-to-time, particularly as technology changes. You can always check this page for the latest version. We may also notify you of changes to our privacy policy by email.

Contacting JD Supra

If you have any questions about how we use cookies and other tracking technologies, please contact us at: privacy@jdsupra.com.

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This website uses cookies to improve user experience, track anonymous site usage, store authorization tokens and permit sharing on social media networks. By continuing to browse this website you accept the use of cookies. Click here to read more about how we use cookies.